Freedom Metaphyseal Cone Implants (Metaphyseal Cones)— 510(k) K252777

Name: FDA 510(k) clearance K252777
Creator: U.S. Food and Drug Administration
Published: 2025-10-31

Substantially Equivalent

Maxx Orthopedics, Inc.

FDA 510(k) clearance K252777 for Freedom Metaphyseal Cone Implants (Metaphyseal Cones), Substantially Equivalent on 2025-10-31. Applicant: Maxx Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Maxx Orthopedics, Inc.
Product code: Code MBH
Device class: Class 2
Regulation: 21 CFR 888.3565
Advisory panel: Orthopedic
Date received: 2025-09-02
Decision date: 2025-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norristown, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.